Evidence map›Paper›PMID 42803717›Full record

Observational studyPharmacoepidemiology and drug safety2026

Pregnancy Outcome After First-Trimester Exposure to Statins: Study Results Based on the Embryotox Cohort.

Evelin Beck, Andrea T Adelsberger, Katarina Dathe

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Pharmacoepidemiology and drug safety, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Evelin BeckCharité-University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Centre of Clinical Teratology and Drug Safety in Pregnancy, Berlin, Germany.ORCID https://orcid.org/0000-0003-1008-8563
Andrea T AdelsbergerCharité-University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Centre of Clinical Teratology and Drug Safety in Pregnancy, Berlin, Germany.
Katarina DatheCharité-University Medical Center Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Clinical Pharmacology and Toxicology, Embryotox Centre of Clinical Teratology and Drug Safety in Pregnancy, Berlin, Germany.ORCID https://orcid.org/0000-0002-8674-5817

Funding

Bundesinstitut für Arzneimittel und Medizinprodukte FKZ V-2020.10/68605/2022-2025
6 · The paper itself

Abstract

purposeThis observational cohort study aimed to assess the risk of adverse pregnancy and neonatal outcomes in pregnancies exposed to statins during the first trimester, given that the use of statins during pregnancy remains controversial. The primary study endpoints were the rates of spontaneous abortion and major birth defects.

methodsIn total, 188 pregnancies exposed to statins in the first trimester were compared with a cohort of 564 pregnancies without the study medication, which were recorded at the Embryotox Centre between January 2000 and June 2021. The effect of statin exposure on pregnancy outcome was estimated using Cox proportional hazards regression models. Log-binomial regression was used to evaluate the risk of major birth defects.

resultsMajor birth defects were observed in 10 of 135 (7.4%) infants in the statin cohort and in 12 of 501 (2.4%) infants in the comparison cohort (RR 3.09, 95% CI 1.37-7.00). After adjustment for relevant baseline covariates and additional maternal disease factors, the difference substantially attenuated (RRadj 2.16; 95% CI 0.88-5.31). The cumulative incidence of spontaneous abortion was 26.8% in the statin-exposed versus 15.0% in the comparison cohort (HR 1.86, 95% CI 1.13-3.04; HRadj 1.66, 95% CI 0.99-2.78).

conclusionsCurrent evidence suggests that statins are not major teratogens. The observed associations between statin exposure and birth defects, as well as unfavourable pregnancy outcomes, are presumably influenced by confounding factors such as underlying maternal disease. Our study results lend support to this assumption. However, they should be interpreted cautiously due to the limited cohort size.

Indexed as

Abnormalities, Drug-InducedAbortion, SpontaneousHydroxymethylglutaryl-CoA Reductase InhibitorsPregnancy OutcomeAdultCohort StudiesFemaleHumansInfant, NewbornPregnancyPregnancy Trimester, FirstProportional Hazards ModelsHydroxymethylglutaryl-CoA Reductase Inhibitorsabortions, spontaneous (MeSH)congenital abnormalities (MeSH)hydroxymethylglutaryl‐CoA reductase inhibitors (MeSH)pharmacovigilance (MeSH)pregnancy outcome (MeSH)

Identifiers

PMID42803717
PMCPMC13618450

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.